INTERSTIM FOR URINARY CONTROL
FDA premarket approval P970004/S041 · decided 2007-11-07
Approval details
- PMA number
- P970004
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTERSTIM FOR URINARY CONTROL
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2007-08-31
- Decision date
- 2007-11-07
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL OR SOFTWARE CHANGES TO THE MODEL 8840 N?VISION PROGRAMMING SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |